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Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.

11 de novembro de 2026 atualizado por: Ben J. Edwards, PhD, Liverpool John Moores University

This study aims to implement a rigorously standardized protocol to investigate the effect of acute (60 min prior) caffeine intake or hypoxia (1000m and 2000m) on 4km time trial performance.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Time-trial performance is widely regarded as the gold-standard measure of endurance exercise capacity, because successful performance depends on completing a fixed distance in the shortest possible time while effectively regulating pacing strategy and power output. As a result, time-trial performance is considered as one of the most ecologically valid measures of endurance performance in both laboratory investigations and applied sport settings. For many endurance athletes, training and competition frequently occur during the morning due to event scheduling, travel requirements and environmental considerations. However, the morning period is characterised by several time-of-day-related physiological differences that may negatively influence exercise performance. Although systematic reviews have reported substantial variability in the magnitude of diurnal fluctuations in time-trial performance, evidence from well-controlled laboratory studies using fixed-distance protocols under thermoneutral conditions consistently indicates superior performance during the late afternoon or evening. Specifically, improvements in evening performance have been observed across a range of endurance modalities, including 100-m swimming (2.6%), 1-km cycling (2.3%), 4-km cycling (2.6%), 10-km cycling (2.3%), 10-km treadmill running (6.3%), and 16.1-km cycling (3.6%). These findings suggest that morning time-trial performance may be compromised relative to later times-of-day, potentially due to circadian variations in physiological and psychological readiness for exercise. Given that athletes are often required to compete in the morning despite these potential limitations, identifying practical and effective strategies to enhance morning time-trial performance is of considerable interest to athletes, coaches and practitioners seeking to optimise competitive outcomes.

Among the nutritional strategies proposed to improve morning performance, acute caffeine ingestion remains one of the most widely consumed and extensively studied ergogenic aids. Caffeine (1,3,7-trimethylxanthine) primarily exerts its performance-enhancing effects through antagonism of adenosine receptors in the central nervous system, resulting in increased arousal, reduced perceptions of fatigue, and enhanced neurotransmitter activity, including dopamine and noradrenaline. These neurophysiological effects collectively promote wakefulness, attention and central motor drive, thereby facilitating exercise performance. Consistent with these mechanisms, substantial evidence demonstrates that caffeine can improve endurance exercise capacity and time-trial performance across a variety of exercise modalities. Despite the well-established ergogenic effects of caffeine, research examining its efficacy during morning time-trial exercise remains comparatively limited. Interpretation of the available literature is further complicated by several methodological shortcomings, including inconsistent caffeine dosing protocols, inadequate familiarisation procedures and poor control of habitual caffeine intake. Recognising the importance of habitual caffeine consumption as a moderator of physiological and performance responses, recent classification thresholds have been proposed. Categorising individuals as naïve (<25 mg·day-¹), low (25 mg·day-¹ to 0.99 mg·kg-¹·day-¹), mild (1.00-2.99 mg·kg-¹·day-¹), moderate (3.00-5.99 mg·kg-¹·day-¹), high (6.00-8.99 mg·kg-¹·day-¹), and very high (>9.00 mg·kg-¹·day-¹) caffeine consumers. Failure to adequately characterise and control habitual caffeine intake may therefore contribute to the variability observed across studies.

Additional methodological limitations within the existing literature include the absence of both placebo and no-pill comparator conditions, together with insufficient control of key chronobiological variables such as chronotype, sleep quality, habitual training time, and seasonal influences. These factors are particularly relevant given their established influence on exercise performance and their potential to confound assessments of both circadian variation and caffeine-related ergogenic effects. Indeed, recent systematic reviews have identified substantial methodological heterogeneity and risk of bias across chronobiology studies, highlighting the need for more rigorous and standardised experimental designs when investigating time-of-day effects on exercise performance. Consequently, well-controlled studies are required to determine whether acute caffeine ingestion can meaningfully attenuate the physiological disadvantages associated with morning endurance exercise and improve time-trial performance under ecologically valid conditions.

Therefore, the primary aim of the present study was to determine whether the ergogenic effects of acute caffeine (CAFF) ingestion, administered 60-min before exercise, enhance morning 4-km cycling time-trial performance when evaluated when behavioural, methodological and chronobiological confounders were carefully controlled. Habitual caffeine consumers with an intake of >150 mg·day-¹ were recruited to minimise the potential influence of caffeine tolerance and withdrawal, while maximising the physiological response to the administered 300 mg caffeine dose. Secondary outcomes included measures of core and skin temperature, ratings of perceived exertion (RPE), mood-state and physiological responses to exercise.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Merseyside
      • Liverpool, Merseyside, Reino Unido, L3 3AF
        • Recrutamento
        • Tom Reilly Building
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 30 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age: 18-30 years old
  • Healthy (as determined by the pre-participation questionnaire)
  • >2 years aerobically trained individuals
  • Consume >150 mg/day of caffeine
  • Be able to stick to the retiring and waking schedule of the study as well as no exercise 24 h before and no caffeine.

Exclusion Criteria:

  • Age: <18 or >30 years old
  • Consume <150 mg/day of caffeine hence caffeine naïve
  • Those with a history of significant side effects after the consumption of caffeine.
  • Deemed unhealthy/unable to perform exercise determined by PAR-Q
  • Shift worker or having travelled out of the UK time zone within the last month of testing
  • Muscle related injury or broken/fractured bone within the past 3 years Diagnosed sleep disorder

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: ABCDE

Control, Placebo, Caffeine, 1000m, 2000m,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Outros nomes:
  • Cafeína
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Outros nomes:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Outros nomes:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Outros nomes:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Outros nomes:
  • 2000 m
Experimental: BCDEA

Placebo, Caffeine, 1000m, 2000m, Control,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Outros nomes:
  • Cafeína
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Outros nomes:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Outros nomes:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Outros nomes:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Outros nomes:
  • 2000 m
Experimental: CDEAB

Caffeine, 1000m, 2000m, Control, Placebo,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Outros nomes:
  • Cafeína
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Outros nomes:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Outros nomes:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Outros nomes:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Outros nomes:
  • 2000 m
Experimental: DEABC

2000m, Control, Placebo, Caffeine, 1000m,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Outros nomes:
  • Cafeína
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Outros nomes:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Outros nomes:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Outros nomes:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Outros nomes:
  • 2000 m
Experimental: EABCD

1000m, 2000m, Control, Placebo, Caffeine, Caffeine,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Outros nomes:
  • Cafeína
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Outros nomes:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Outros nomes:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Outros nomes:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Outros nomes:
  • 2000 m

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
4km time to completion
Prazo: 5 weeks

How long does the participant take to complete 4km cycling

5 weeks
Average power
Prazo: 5 weekas

Average power sustained through the 4km

5 weekas

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Cognitive function
Prazo: 5 weeks

Stroop word-colour interference test

5 weeks
Witty
Prazo: 5 weeks

Light reaction test

5 weeks
Memory test
Prazo: 5 weeks

Rey's Auditory Verbal Learning test

5 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de novembro de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

5 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de novembro de 2026

Primeira postagem (Real)

13 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 261020LJMUSPSREC348

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .